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NCT Number: NCT03865914

Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy

With the rapid increase of diabetic nephropathy worldwide, type 2 diabetes mellitus(DM) is the leading cause of end-stage renal disease(ESRD). Pathological types of diabetic kidney disease(DKD) could be mainly divided into diabetic nephropathy（DN）and non-diabetic renal diseases（NDRD）. There are no accurate renal biopsy indications and standardized operation procedures for type 2 diabetic nephropathy. The clinical stages of type 2 diabetic nephropathy still referred to the Mogensen stage of type 1 diabetic nephropathy. Thus, our study aim to clarify the differences in clinical phenotype between type 2 DN and type 2 NDRD, analysis the correlation between clinical and pathological features, and offer the criteria for clinical staging and prognosis.

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≥18, male or female
  • Clinical diagnosed as type 2 diabetes mellitus
  • The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency
  • The renal biopsy was performed with complete renal pathological diagnosis
  • Obtaining the signed informed consent from patients

Exclusion criteria

  • The history of the disease was not complete
  • Clinical diagnosed as other secondary renal diseases
  • Patients with hereditary kidney disease
  • Autoimmune diseases
  • Patients with malignant tumor were expected to survive less than 6 months
  • Pregnancy and lactation

Treatment and study plan

Primary outcomes

  1. change in eGFR and urine protein from baseline

    Time frame: 24months

    eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangmei Chen, MD.&Ph.D

CONTACT

[email protected]

+86 010 66935462

Zheyi Dong, MD.&Ph.D

CONTACT

[email protected]

+86 010 66935462

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Friendship Hospital
  • Beijing Hospital
  • Beijing Municipal Science & Technology Commission
  • China-Japan Friendship Hospital
  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Dongzhimen Hospital, Beijing
  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
  • Fourth Medical Center of PLA General Hospital
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Shanghai University of Traditional Chinese Medicine
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Dalian Medical University
  • Third Medical Center of Chinese PLA General Hospital

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2030
First posted
Mar 7, 2019
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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